Omalizumab, Xolair
Description: Monoclonal Antibody; Anti-Asthmatic
“ALERT: US Boxed Warning
Anaphylaxis:
Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after the administration of omalizumab. Anaphylaxis has occurred as early as after the first dose of omalizumab but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after omalizumab administration. Health care providers administering omalizumab should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care if symptoms occur.”
CSA NA – FDA Approved – REMS (N) – Can Ship
How Does It Work
Omalizumab, Xolair is a recombinant DNA IgG monoclonal antibody which blocks the high-affinity IgE receptor on mast cells and basophils. Decreasing bound IgE, the activation and release of allergic response mediators is reduced. Serum free IgE levels and the number of high-affinity IgE receptors are decreased. Long-term treatment in patients with allergic asthma showed a decrease in asthma exacerbations and corticosteroid usage. The mechanism by which these effects of omalizumab result in an improvement of chronic idiopathic urticaria symptoms is unknown.
Indications For Use
Asthma; Chronic Idiopathic Urticaria
Precautions
Before starting Omalizumab, Xolair makes sure your physician is aware of any allergies or medications you currently take, if you are high risk for parasitic helminth infections, are pregnant, or breastfeeding. Omalizumab, Xolair use has been associated with rare but serious adverse events such as cerebrovascular effects, eosinophilia, vasculitis, fever, arthralgia, rash, hypersensitivity reactions, and malignant neoplasms.
Usual Dosing
Dose and frequency based on body weight and pre-treatment total IgE serum levels.
Pharmacist Tips On Using
How to Take: Administer via subcutaneous injection. No more than 150mg should be injected in one injection site. Doses over 150mg should be divided into multiple injections of no more than 150mg per injection. Each injection site should be separated by ≥1 inch. Injections may take 5 to 10 seconds to administer (solution is slightly viscous). Administer only under direct medical supervision and observe patient for 2 hours after the first 3 injections and 30 minutes after subsequent injections or in accordance with individual institution policies and procedures. Store under refrigeration at 2°C to 8°C (36°F to 46°F) in the original carton and protect from direct sunlight.
You Need to Avoid: Do not inject into moles, scars, bruises, tender areas, or broken skin. Do not freeze the product.
Side Effects
Headache, injection site reaction, pain, arthralgia, nasopharyngitis, sinusitis
Note this is not a complete list
Frequently Asked Questions
I am having breakthrough symptoms, what do I do?
Use a rescue inhaler such as salbutamol as per the asthma action plan for immediate relief. Omalizumab therapy has not been shown to alleviate acute asthma exacerbations; do not use to treat acute bronchospasm, status asthmaticus, or other allergic conditions.